AAD Annual Meeting 2018

SAN DIEGO – In assessing tumor-free margins during Mohs micrographic surgery for skin cancer, bioimpedance spectroscopy was highly sensitive and specific for detecting residual cancer cells, compared with standard microscopy of histologic sections, in a single-center, pilot study of bioimpedance in 151 specimens from 50 consecutive patients.

If the finding of high diagnostic accuracy using bioimpedance spectroscopy is confirmed in larger numbers of patients and specimens run at multiple sites, this approach could “potentially revolutionize what happens with the way Mohs sections are processed in the future” by potentially shaving many minutes off the duration of a standard procedure, Darrell S. Rigel, MD, said in a video interview during the annual meeting of the American Academy of Dermatology.

Usually, it takes 10-20 minutes to process and examine Mohs specimens at each stage of the surgical procedure to determine whether additional excision must remove residual cancer cells, said Dr. Rigel, a dermatologist at New York University. In contrast, assessment for residual cancer cells in the surgical field takes less than a minute using bioimpedance spectroscopy, which relies on differences in electrical conductivity between benign and cancerous cells to identify cancer cells remaining at the surgical margins.

The results of the study were presented in a poster at the meeting, by a research associate of Dr. Rigel’s, Ryan Svoboda, MD, of the National Society for Cutaneous Medicine, New York.

The researchers used a bioimpedance spectroscopy device made by NovaScan to assess 151 histology slides prepared during Mohs micrographic surgery on patients with nonmelanoma skin cancer, and compared the findings against the gold standard of histological slide examination. By this criterion, bioimpedance spectroscopy identified 105 true negatives and 2 false negatives, and 43 true positives and 1 false positive. Calculations showed that this equated to 95.6% sensitivity, 99.1% specificity, a 97.7% positive predictive value, and a 98.1% negative predictive value.

These may be underestimates of the accuracy of bioimpedance spectroscopy because the calculations presume that conventional histology is always correct, but Dr. Rigel noted that sometimes the histological diagnosis is wrong.

mzoler@frontlinemedcom.com

SOURCE: Svoboda R et al. Poster 7304.

SAN DIEGO – In assessing tumor-free margins during Mohs micrographic surgery for skin cancer, bioimpedance spectroscopy was highly sensitive and specific for detecting residual cancer cells, compared with standard microscopy of histologic sections, in a single-center, pilot study of bioimpedance in 151 specimens from 50 consecutive patients.

If the finding of high diagnostic accuracy using bioimpedance spectroscopy is confirmed in larger numbers of patients and specimens run at multiple sites, this approach could “potentially revolutionize what happens with the way Mohs sections are processed in the future” by potentially shaving many minutes off the duration of a standard procedure, Darrell S. Rigel, MD, said in a video interview during the annual meeting of the American Academy of Dermatology.

Usually, it takes 10-20 minutes to process and examine Mohs specimens at each stage of the surgical procedure to determine whether additional excision must remove residual cancer cells, said Dr. Rigel, a dermatologist at New York University. In contrast, assessment for residual cancer cells in the surgical field takes less than a minute using bioimpedance spectroscopy, which relies on differences in electrical conductivity between benign and cancerous cells to identify cancer cells remaining at the surgical margins.

The results of the study were presented in a poster at the meeting, by a research associate of Dr. Rigel’s, Ryan Svoboda, MD, of the National Society for Cutaneous Medicine, New York.

The researchers used a bioimpedance spectroscopy device made by NovaScan to assess 151 histology slides prepared during Mohs micrographic surgery on patients with nonmelanoma skin cancer, and compared the findings against the gold standard of histological slide examination. By this criterion, bioimpedance spectroscopy identified 105 true negatives and 2 false negatives, and 43 true positives and 1 false positive. Calculations showed that this equated to 95.6% sensitivity, 99.1% specificity, a 97.7% positive predictive value, and a 98.1% negative predictive value.

These may be underestimates of the accuracy of bioimpedance spectroscopy because the calculations presume that conventional histology is always correct, but Dr. Rigel noted that sometimes the histological diagnosis is wrong.

mzoler@frontlinemedcom.com

SOURCE: Svoboda R et al. Poster 7304.

SAN DIEGO – In assessing tumor-free margins during Mohs micrographic surgery for skin cancer, bioimpedance spectroscopy was highly sensitive and specific for detecting residual cancer cells, compared with standard microscopy of histologic sections, in a single-center, pilot study of bioimpedance in 151 specimens from 50 consecutive patients.

If the finding of high diagnostic accuracy using bioimpedance spectroscopy is confirmed in larger numbers of patients and specimens run at multiple sites, this approach could “potentially revolutionize what happens with the way Mohs sections are processed in the future” by potentially shaving many minutes off the duration of a standard procedure, Darrell S. Rigel, MD, said in a video interview during the annual meeting of the American Academy of Dermatology.

Usually, it takes 10-20 minutes to process and examine Mohs specimens at each stage of the surgical procedure to determine whether additional excision must remove residual cancer cells, said Dr. Rigel, a dermatologist at New York University. In contrast, assessment for residual cancer cells in the surgical field takes less than a minute using bioimpedance spectroscopy, which relies on differences in electrical conductivity between benign and cancerous cells to identify cancer cells remaining at the surgical margins.

The results of the study were presented in a poster at the meeting, by a research associate of Dr. Rigel’s, Ryan Svoboda, MD, of the National Society for Cutaneous Medicine, New York.

The researchers used a bioimpedance spectroscopy device made by NovaScan to assess 151 histology slides prepared during Mohs micrographic surgery on patients with nonmelanoma skin cancer, and compared the findings against the gold standard of histological slide examination. By this criterion, bioimpedance spectroscopy identified 105 true negatives and 2 false negatives, and 43 true positives and 1 false positive. Calculations showed that this equated to 95.6% sensitivity, 99.1% specificity, a 97.7% positive predictive value, and a 98.1% negative predictive value.

These may be underestimates of the accuracy of bioimpedance spectroscopy because the calculations presume that conventional histology is always correct, but Dr. Rigel noted that sometimes the histological diagnosis is wrong.

mzoler@frontlinemedcom.com

SOURCE: Svoboda R et al. Poster 7304.

SAN DIEGO – An anti–interleukin-33 antibody aimed at atopic dermatitis performed reasonably well in a small, proof-of-concept phase 2a study, and will proceed along its developmental pathway.

All 12 patients who received one intravenous infusion of ANB020 achieved at least a 50% reduction in their Eczema Area and Severity Index (EASI) by day 29, Graham Ogg, MD, said at the annual meeting of the American Academy of Dermatology. Most of the improvement occurred in the first 2 weeks, was largely sustained for 2 months, then gradually began to fade, said Dr. Ogg, professor of dermatology at Oxford University, England.

The EASI improvement, along with improvements in itch and clinical assessment, are enough to propel ANB020 into a phase 2b, placebo-controlled, randomized trial, which Dr. Ogg said would recruit 200 to 300 adults with moderate to severe atomic dermatitis (AD).

ANB020 is a selective inhibitor of interleukin-33 (IL-33), which is highly expressed in the lesions of AD, Dr. Ogg said. “IL-33 is produced by a number of cells, including keratinocytes and epithelial cells. It’s an alarm molecule predominately produced after damage to keratinocytes; for example, after an allergenic challenge to the skin.”

The antibody has already passed its phase 1 trials, which included both a fixed and ascending dose study of 10 mg to 750 mg in healthy adults. ANB020 has a long half-life of 16 days after IV infusion or subcutaneous injection, inhibits IL-33 for up to 85 days, and has no apparent dose-limiting toxicities.

The phase 2a study comprised 12 adults (mean age 40 years) with a mean EASI score of 32, Dr. Ogg reported. The mean Investigator’s Global Assessment score was 4, and the mean Severity Scoring of Atopic Dermatitis almost 65. Patients had high itch scores and scored a mean of 13 on the Dermatology Life Quality Index. All were inadequately controlled on topical corticosteroids, and about half had failed at least one systemic immunomodulator.

Following a washout period, all subjects received an initial placebo infusion, and 1 week later received a single 300-mg infusion of ANB020. The primary endpoint – at least a 50% reduction in EASI score (EASI-50) – was assessed at day 29, with close follow-up until day 140.

By day 15, nine patients (75%) had achieved EASI-50, and three (25%) had achieved a 75% reduction in EASI score (EASI-75). The average EASI score reduction was 58% at that point. By day 29, 10 (83%) had achieved EASI-50, and 4 (33%), EASI-75. This benefit was largely maintained until day 78, when it began to tail off somewhat. By day 140, five patients (42%) still had an EASI-50 and three (25%), an EASI-75.

Three patients (25%) achieved an Investigator’s Global Assessment score of 0 or 1, indicating clear or almost clear skin. On day 29, the average pruritus decrease was 32%, which dropped to 21% by day 140. The average Severity Scoring of Atopic Dermatitis reduction was 40% on day 29 and 32% on day 140. The average Dermatology Life Quality Index reduction was 45% on day 29 and 43% on day 140.

ANB020 was well tolerated with no drug-related safety signals. Dizziness occurred in 17% of subjects, and mild headache in 25%. There was one serious adverse event, a case of major depression that occurred on day 140. This was consistent with the patient’s baseline health history and deemed unrelated to the study drug.

According to an AnaptysBio press release, ANB020 is also being investigated in a double-blind, placebo-controlled study of 20 adults with severe peanut allergy. The company also is enrolling a 24-patient randomized, double-blind, placebo-controlled, phase 2a trial in adults with severe eosinophilic asthma.

Topline data from both of these studies are expected soon, the website noted.

AnaptysBio funded Dr. Ogg’s travel and registration fees for the meeting. He said he had no other financial disclosures relevant to ANB020.

msullivan@frontlinemedcom.com

SOURCE: Ogg G et al. AAD 2018. Abstract 6658.

SAN DIEGO – An anti–interleukin-33 antibody aimed at atopic dermatitis performed reasonably well in a small, proof-of-concept phase 2a study, and will proceed along its developmental pathway.

All 12 patients who received one intravenous infusion of ANB020 achieved at least a 50% reduction in their Eczema Area and Severity Index (EASI) by day 29, Graham Ogg, MD, said at the annual meeting of the American Academy of Dermatology. Most of the improvement occurred in the first 2 weeks, was largely sustained for 2 months, then gradually began to fade, said Dr. Ogg, professor of dermatology at Oxford University, England.

The EASI improvement, along with improvements in itch and clinical assessment, are enough to propel ANB020 into a phase 2b, placebo-controlled, randomized trial, which Dr. Ogg said would recruit 200 to 300 adults with moderate to severe atomic dermatitis (AD).

ANB020 is a selective inhibitor of interleukin-33 (IL-33), which is highly expressed in the lesions of AD, Dr. Ogg said. “IL-33 is produced by a number of cells, including keratinocytes and epithelial cells. It’s an alarm molecule predominately produced after damage to keratinocytes; for example, after an allergenic challenge to the skin.”

The antibody has already passed its phase 1 trials, which included both a fixed and ascending dose study of 10 mg to 750 mg in healthy adults. ANB020 has a long half-life of 16 days after IV infusion or subcutaneous injection, inhibits IL-33 for up to 85 days, and has no apparent dose-limiting toxicities.

The phase 2a study comprised 12 adults (mean age 40 years) with a mean EASI score of 32, Dr. Ogg reported. The mean Investigator’s Global Assessment score was 4, and the mean Severity Scoring of Atopic Dermatitis almost 65. Patients had high itch scores and scored a mean of 13 on the Dermatology Life Quality Index. All were inadequately controlled on topical corticosteroids, and about half had failed at least one systemic immunomodulator.

Following a washout period, all subjects received an initial placebo infusion, and 1 week later received a single 300-mg infusion of ANB020. The primary endpoint – at least a 50% reduction in EASI score (EASI-50) – was assessed at day 29, with close follow-up until day 140.

By day 15, nine patients (75%) had achieved EASI-50, and three (25%) had achieved a 75% reduction in EASI score (EASI-75). The average EASI score reduction was 58% at that point. By day 29, 10 (83%) had achieved EASI-50, and 4 (33%), EASI-75. This benefit was largely maintained until day 78, when it began to tail off somewhat. By day 140, five patients (42%) still had an EASI-50 and three (25%), an EASI-75.

Three patients (25%) achieved an Investigator’s Global Assessment score of 0 or 1, indicating clear or almost clear skin. On day 29, the average pruritus decrease was 32%, which dropped to 21% by day 140. The average Severity Scoring of Atopic Dermatitis reduction was 40% on day 29 and 32% on day 140. The average Dermatology Life Quality Index reduction was 45% on day 29 and 43% on day 140.

ANB020 was well tolerated with no drug-related safety signals. Dizziness occurred in 17% of subjects, and mild headache in 25%. There was one serious adverse event, a case of major depression that occurred on day 140. This was consistent with the patient’s baseline health history and deemed unrelated to the study drug.

According to an AnaptysBio press release, ANB020 is also being investigated in a double-blind, placebo-controlled study of 20 adults with severe peanut allergy. The company also is enrolling a 24-patient randomized, double-blind, placebo-controlled, phase 2a trial in adults with severe eosinophilic asthma.

Topline data from both of these studies are expected soon, the website noted.

AnaptysBio funded Dr. Ogg’s travel and registration fees for the meeting. He said he had no other financial disclosures relevant to ANB020.

msullivan@frontlinemedcom.com

SOURCE: Ogg G et al. AAD 2018. Abstract 6658.

SAN DIEGO – An anti–interleukin-33 antibody aimed at atopic dermatitis performed reasonably well in a small, proof-of-concept phase 2a study, and will proceed along its developmental pathway.

All 12 patients who received one intravenous infusion of ANB020 achieved at least a 50% reduction in their Eczema Area and Severity Index (EASI) by day 29, Graham Ogg, MD, said at the annual meeting of the American Academy of Dermatology. Most of the improvement occurred in the first 2 weeks, was largely sustained for 2 months, then gradually began to fade, said Dr. Ogg, professor of dermatology at Oxford University, England.

The EASI improvement, along with improvements in itch and clinical assessment, are enough to propel ANB020 into a phase 2b, placebo-controlled, randomized trial, which Dr. Ogg said would recruit 200 to 300 adults with moderate to severe atomic dermatitis (AD).

ANB020 is a selective inhibitor of interleukin-33 (IL-33), which is highly expressed in the lesions of AD, Dr. Ogg said. “IL-33 is produced by a number of cells, including keratinocytes and epithelial cells. It’s an alarm molecule predominately produced after damage to keratinocytes; for example, after an allergenic challenge to the skin.”

The antibody has already passed its phase 1 trials, which included both a fixed and ascending dose study of 10 mg to 750 mg in healthy adults. ANB020 has a long half-life of 16 days after IV infusion or subcutaneous injection, inhibits IL-33 for up to 85 days, and has no apparent dose-limiting toxicities.

The phase 2a study comprised 12 adults (mean age 40 years) with a mean EASI score of 32, Dr. Ogg reported. The mean Investigator’s Global Assessment score was 4, and the mean Severity Scoring of Atopic Dermatitis almost 65. Patients had high itch scores and scored a mean of 13 on the Dermatology Life Quality Index. All were inadequately controlled on topical corticosteroids, and about half had failed at least one systemic immunomodulator.

Following a washout period, all subjects received an initial placebo infusion, and 1 week later received a single 300-mg infusion of ANB020. The primary endpoint – at least a 50% reduction in EASI score (EASI-50) – was assessed at day 29, with close follow-up until day 140.

By day 15, nine patients (75%) had achieved EASI-50, and three (25%) had achieved a 75% reduction in EASI score (EASI-75). The average EASI score reduction was 58% at that point. By day 29, 10 (83%) had achieved EASI-50, and 4 (33%), EASI-75. This benefit was largely maintained until day 78, when it began to tail off somewhat. By day 140, five patients (42%) still had an EASI-50 and three (25%), an EASI-75.

Three patients (25%) achieved an Investigator’s Global Assessment score of 0 or 1, indicating clear or almost clear skin. On day 29, the average pruritus decrease was 32%, which dropped to 21% by day 140. The average Severity Scoring of Atopic Dermatitis reduction was 40% on day 29 and 32% on day 140. The average Dermatology Life Quality Index reduction was 45% on day 29 and 43% on day 140.

ANB020 was well tolerated with no drug-related safety signals. Dizziness occurred in 17% of subjects, and mild headache in 25%. There was one serious adverse event, a case of major depression that occurred on day 140. This was consistent with the patient’s baseline health history and deemed unrelated to the study drug.

According to an AnaptysBio press release, ANB020 is also being investigated in a double-blind, placebo-controlled study of 20 adults with severe peanut allergy. The company also is enrolling a 24-patient randomized, double-blind, placebo-controlled, phase 2a trial in adults with severe eosinophilic asthma.

Topline data from both of these studies are expected soon, the website noted.

AnaptysBio funded Dr. Ogg’s travel and registration fees for the meeting. He said he had no other financial disclosures relevant to ANB020.

msullivan@frontlinemedcom.com

SOURCE: Ogg G et al. AAD 2018. Abstract 6658.

SAN DIEGO – SPF 100 was more effective for preventing sunburn than was sunscreen with a 50 rating, a finding that might interest consumers and prompt the Food and Drug Administration to continue to allow sunscreens to have labels listing sun protection factors greater than 50.*

“Our study results show pretty definitively that SPF 100 did significantly better than SPF 50 in a real world environment,” Darrell S. Rigel, MD, said at the annual meeting of the American Academy of Dermatology.

Dr. Rigel cited data that he and his associates recently published from 199 adults skiing on a sunny March day in Colorado. Participants applied a blinded sunscreen rated at SPF 50 to one side of their face all day and an SPF 100 sunscreen to the other side all day, and the researchers then ran a blinded assessment of images taken of each side at the end of the day. The sunburn on the SPF 50 side exceeded the other side in 55% of skiers, the two sides matched in 40%, and in 5% the sunburn was worse on the SPF 100 side (J Am Acad Dermatol. 2017 Dec 29. doi: 10.1016/j.jaad.2017.12.062).

“The SPF 50 side of the face was 11 times more likely to be sunburned than the SPF 100 side,” and for all the secondary endpoints and different ways of analyzing the data, the SPF 50 was not as effective as SPF 100, Dr. Rigel said in a video interview. Erythema appeared on 41% of the SPF 50–treated sides of participants faces, compared with 14% of the sides treated with SPF 100 sunscreen.

The results followed-up on a report from Dr. Rigel and his associates from 8 years ago that ran a similar comparison of two sunscreen potencies, SPF 85 and SPF 50, in 56 skiers, with similar results showing greater sunburn protection from the higher SPF sunscreen (J Am Acad Dermatol. 2010 Feb;62[2]:348-9). In 2011, the FDA proposed a new rule for SPF labeling that would cap the maximum SPF potency possible of 50, which created a label 50+ to designate unspecified SPF above 50. According to Dr. Rigel, the FDA rejected his 2010 study as documentation of incremental benefit above SPF 50 because of several flaws the agency found with that study, including not tracking sunscreen use by weight. He specifically designed the new, 199-subject study to address that and the FDA’s other concerns.

He and his associates decided to do the study because the FDA said in the monograph that, if the concerns were met, “they would accept the study as definitive,” said Dr. Rigel, a dermatologist at New York University.

The greater protection from SPF 100 sunscreen probably occurs because it’s “more forgiving” when used with inadequate application, he suggested. Allowing labeling that specifies SPF levels greater than 50 would help consumers pick sunscreen formulations that give greater protection, and it would encourage manufacturers to market sunscreens with higher SPF levels.

Dr. Rigel has been a consultant to Castle Biosciences, DermTech, Ferndale, Myriad, Neutrogena, and Novascan and has received research support from Castle and Neutrogena.

mzoler@frontlinemedcom.com

Correction, 2/22/18: Due to an editing error, an earlier version of this article implied incorrectly that sunscreen labels listing SPFs over 50 had been banned .

SAN DIEGO – SPF 100 was more effective for preventing sunburn than was sunscreen with a 50 rating, a finding that might interest consumers and prompt the Food and Drug Administration to continue to allow sunscreens to have labels listing sun protection factors greater than 50.*

“Our study results show pretty definitively that SPF 100 did significantly better than SPF 50 in a real world environment,” Darrell S. Rigel, MD, said at the annual meeting of the American Academy of Dermatology.

Dr. Rigel cited data that he and his associates recently published from 199 adults skiing on a sunny March day in Colorado. Participants applied a blinded sunscreen rated at SPF 50 to one side of their face all day and an SPF 100 sunscreen to the other side all day, and the researchers then ran a blinded assessment of images taken of each side at the end of the day. The sunburn on the SPF 50 side exceeded the other side in 55% of skiers, the two sides matched in 40%, and in 5% the sunburn was worse on the SPF 100 side (J Am Acad Dermatol. 2017 Dec 29. doi: 10.1016/j.jaad.2017.12.062).

“The SPF 50 side of the face was 11 times more likely to be sunburned than the SPF 100 side,” and for all the secondary endpoints and different ways of analyzing the data, the SPF 50 was not as effective as SPF 100, Dr. Rigel said in a video interview. Erythema appeared on 41% of the SPF 50–treated sides of participants faces, compared with 14% of the sides treated with SPF 100 sunscreen.

The results followed-up on a report from Dr. Rigel and his associates from 8 years ago that ran a similar comparison of two sunscreen potencies, SPF 85 and SPF 50, in 56 skiers, with similar results showing greater sunburn protection from the higher SPF sunscreen (J Am Acad Dermatol. 2010 Feb;62[2]:348-9). In 2011, the FDA proposed a new rule for SPF labeling that would cap the maximum SPF potency possible of 50, which created a label 50+ to designate unspecified SPF above 50. According to Dr. Rigel, the FDA rejected his 2010 study as documentation of incremental benefit above SPF 50 because of several flaws the agency found with that study, including not tracking sunscreen use by weight. He specifically designed the new, 199-subject study to address that and the FDA’s other concerns.

He and his associates decided to do the study because the FDA said in the monograph that, if the concerns were met, “they would accept the study as definitive,” said Dr. Rigel, a dermatologist at New York University.

The greater protection from SPF 100 sunscreen probably occurs because it’s “more forgiving” when used with inadequate application, he suggested. Allowing labeling that specifies SPF levels greater than 50 would help consumers pick sunscreen formulations that give greater protection, and it would encourage manufacturers to market sunscreens with higher SPF levels.

Dr. Rigel has been a consultant to Castle Biosciences, DermTech, Ferndale, Myriad, Neutrogena, and Novascan and has received research support from Castle and Neutrogena.

mzoler@frontlinemedcom.com

Correction, 2/22/18: Due to an editing error, an earlier version of this article implied incorrectly that sunscreen labels listing SPFs over 50 had been banned .

SAN DIEGO – SPF 100 was more effective for preventing sunburn than was sunscreen with a 50 rating, a finding that might interest consumers and prompt the Food and Drug Administration to continue to allow sunscreens to have labels listing sun protection factors greater than 50.*

“Our study results show pretty definitively that SPF 100 did significantly better than SPF 50 in a real world environment,” Darrell S. Rigel, MD, said at the annual meeting of the American Academy of Dermatology.

Dr. Rigel cited data that he and his associates recently published from 199 adults skiing on a sunny March day in Colorado. Participants applied a blinded sunscreen rated at SPF 50 to one side of their face all day and an SPF 100 sunscreen to the other side all day, and the researchers then ran a blinded assessment of images taken of each side at the end of the day. The sunburn on the SPF 50 side exceeded the other side in 55% of skiers, the two sides matched in 40%, and in 5% the sunburn was worse on the SPF 100 side (J Am Acad Dermatol. 2017 Dec 29. doi: 10.1016/j.jaad.2017.12.062).

“The SPF 50 side of the face was 11 times more likely to be sunburned than the SPF 100 side,” and for all the secondary endpoints and different ways of analyzing the data, the SPF 50 was not as effective as SPF 100, Dr. Rigel said in a video interview. Erythema appeared on 41% of the SPF 50–treated sides of participants faces, compared with 14% of the sides treated with SPF 100 sunscreen.

The results followed-up on a report from Dr. Rigel and his associates from 8 years ago that ran a similar comparison of two sunscreen potencies, SPF 85 and SPF 50, in 56 skiers, with similar results showing greater sunburn protection from the higher SPF sunscreen (J Am Acad Dermatol. 2010 Feb;62[2]:348-9). In 2011, the FDA proposed a new rule for SPF labeling that would cap the maximum SPF potency possible of 50, which created a label 50+ to designate unspecified SPF above 50. According to Dr. Rigel, the FDA rejected his 2010 study as documentation of incremental benefit above SPF 50 because of several flaws the agency found with that study, including not tracking sunscreen use by weight. He specifically designed the new, 199-subject study to address that and the FDA’s other concerns.

He and his associates decided to do the study because the FDA said in the monograph that, if the concerns were met, “they would accept the study as definitive,” said Dr. Rigel, a dermatologist at New York University.

The greater protection from SPF 100 sunscreen probably occurs because it’s “more forgiving” when used with inadequate application, he suggested. Allowing labeling that specifies SPF levels greater than 50 would help consumers pick sunscreen formulations that give greater protection, and it would encourage manufacturers to market sunscreens with higher SPF levels.

Dr. Rigel has been a consultant to Castle Biosciences, DermTech, Ferndale, Myriad, Neutrogena, and Novascan and has received research support from Castle and Neutrogena.

mzoler@frontlinemedcom.com

Correction, 2/22/18: Due to an editing error, an earlier version of this article implied incorrectly that sunscreen labels listing SPFs over 50 had been banned .

SAN DIEGO – Upadacitinib, a selective inhibitor of the Janus kinase 1 enzyme, affected up to 90% skin clearance in a phase 2 study in patients with moderate to severe atopic dermatitis (AD).

The molecule significantly outperformed placebo with all three of the doses tested, with patients experiencing improvement in itch and skin are involved in the first week of use. During the 16-week trial, there were none of the thromboembolic events that have proven a concern with other inhibitors of the Janus kinase family of enzymes, Emma Guttman, MD, PhD, said at the annual meeting of the American Academy of Dermatology.

The study’s primary endpoint was the mean percent EASI improvement from baseline. Dr. Guttman reported several of the key secondary endpoints as well.

On the primary endpoint, all three doses of upadacitinib separated from placebo quickly and dramatically. Patients began to see some skin clearance after 1 week; by 2 weeks, the 7.5-mg group had achieved a 39% improvement and the 15- and 30-mg groups, 56% and 59% improvement, respectively.

Efficacy in the 7.5-mg group peaked at a 50% improvement by week 4, and then trailed off somewhat, with a mean 39% improvement by week 16.

Efficacy in the two higher dose groups also peaked around 4 weeks, with a 66% improvement in the 15-mg group and a 78% improvement in the 30-mg group. There was some tailing off of effect in each of these groups as well. By 16 weeks, the mean EASI improvement was 61.7% in the 15-mg group and 74.4% in the 30-mg group.

A good number of patients in each dosing group even achieved 90% skin clearance, Dr. Guttman noted.

“We generally say that we like to see an EASI 50, but now we are talking about EASI 75 and even 90. More than 60% on the highest dose achieved an EASI 75 and 60% an EASI 90. Even the 15-mg group achieved a nice EASI 90 response, at around 26%.”

Itching also responded well to upadacitinib, Dr. Guttman said. Within 1 week, all three active groups had separated significantly from the placebo group. By 2 weeks, the 7.5-mg group had a mean 29% improvement on the pruritus numerical rating scale. The improvement was 46% in the 15-mg group and 57.6% in the 30-mg group. By 16 weeks, the improvements were 39.6%, 48%, and 68.9%, respectively, compared with 9.7% among those on placebo.

The most common treatment-emergent adverse event was upper respiratory infection, which Dr. Guttman noted has been seen with JAK inhibitors. This occurred in 10% of those taking placebo and in 16.7% of the 7.5-mg group and 11.9% of both the 15-mg and 30-mg groups. A few patients experienced exacerbation of their AD on the medication (16.7%, 7% and 11.9% of the active groups, compared with 7.5% of those on placebo). New acne developed in 2.5% of placebo patients and in 9.5%, 4.8%, and 14.3% of those taking upadacitinib. The acne was on the body, considered mild, and resolved, Dr. Guttman said.

Two patients taking 7.5 mg and one taking 15 mg developed a serious infection, although she did not elaborate on the illnesses. Two taking 15 mg developed a liver disorder. There were four cases of neutropenia and one lymphopenia, all among the active groups. Creatine phosphokinase elevations occurred in one taking placebo and seven taking the study drug.

There were no pulmonary or deep vein thromboses; no opportunistic infections or malignancies; and no cases of herpes zoster, tuberculosis, or renal dysfunction. There were no deaths during the trial.

Phase 3 studies of upadacitinib in patients with rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease are underway, according to AbbVie.

AbbVie sponsored the AD study. Dr. Guttman is a consultant for the company.
 

msullivan@frontlinemedcom.com

SOURCE: Guttman E et al. AAD late-breaking clinical trials, Abstract 6533

SAN DIEGO – Upadacitinib, a selective inhibitor of the Janus kinase 1 enzyme, affected up to 90% skin clearance in a phase 2 study in patients with moderate to severe atopic dermatitis (AD).

The molecule significantly outperformed placebo with all three of the doses tested, with patients experiencing improvement in itch and skin are involved in the first week of use. During the 16-week trial, there were none of the thromboembolic events that have proven a concern with other inhibitors of the Janus kinase family of enzymes, Emma Guttman, MD, PhD, said at the annual meeting of the American Academy of Dermatology.

The study’s primary endpoint was the mean percent EASI improvement from baseline. Dr. Guttman reported several of the key secondary endpoints as well.

On the primary endpoint, all three doses of upadacitinib separated from placebo quickly and dramatically. Patients began to see some skin clearance after 1 week; by 2 weeks, the 7.5-mg group had achieved a 39% improvement and the 15- and 30-mg groups, 56% and 59% improvement, respectively.

Efficacy in the 7.5-mg group peaked at a 50% improvement by week 4, and then trailed off somewhat, with a mean 39% improvement by week 16.

Efficacy in the two higher dose groups also peaked around 4 weeks, with a 66% improvement in the 15-mg group and a 78% improvement in the 30-mg group. There was some tailing off of effect in each of these groups as well. By 16 weeks, the mean EASI improvement was 61.7% in the 15-mg group and 74.4% in the 30-mg group.

A good number of patients in each dosing group even achieved 90% skin clearance, Dr. Guttman noted.

“We generally say that we like to see an EASI 50, but now we are talking about EASI 75 and even 90. More than 60% on the highest dose achieved an EASI 75 and 60% an EASI 90. Even the 15-mg group achieved a nice EASI 90 response, at around 26%.”

Itching also responded well to upadacitinib, Dr. Guttman said. Within 1 week, all three active groups had separated significantly from the placebo group. By 2 weeks, the 7.5-mg group had a mean 29% improvement on the pruritus numerical rating scale. The improvement was 46% in the 15-mg group and 57.6% in the 30-mg group. By 16 weeks, the improvements were 39.6%, 48%, and 68.9%, respectively, compared with 9.7% among those on placebo.

The most common treatment-emergent adverse event was upper respiratory infection, which Dr. Guttman noted has been seen with JAK inhibitors. This occurred in 10% of those taking placebo and in 16.7% of the 7.5-mg group and 11.9% of both the 15-mg and 30-mg groups. A few patients experienced exacerbation of their AD on the medication (16.7%, 7% and 11.9% of the active groups, compared with 7.5% of those on placebo). New acne developed in 2.5% of placebo patients and in 9.5%, 4.8%, and 14.3% of those taking upadacitinib. The acne was on the body, considered mild, and resolved, Dr. Guttman said.

Two patients taking 7.5 mg and one taking 15 mg developed a serious infection, although she did not elaborate on the illnesses. Two taking 15 mg developed a liver disorder. There were four cases of neutropenia and one lymphopenia, all among the active groups. Creatine phosphokinase elevations occurred in one taking placebo and seven taking the study drug.

There were no pulmonary or deep vein thromboses; no opportunistic infections or malignancies; and no cases of herpes zoster, tuberculosis, or renal dysfunction. There were no deaths during the trial.

Phase 3 studies of upadacitinib in patients with rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease are underway, according to AbbVie.

AbbVie sponsored the AD study. Dr. Guttman is a consultant for the company.
 

msullivan@frontlinemedcom.com

SOURCE: Guttman E et al. AAD late-breaking clinical trials, Abstract 6533

SAN DIEGO – Upadacitinib, a selective inhibitor of the Janus kinase 1 enzyme, affected up to 90% skin clearance in a phase 2 study in patients with moderate to severe atopic dermatitis (AD).

The molecule significantly outperformed placebo with all three of the doses tested, with patients experiencing improvement in itch and skin are involved in the first week of use. During the 16-week trial, there were none of the thromboembolic events that have proven a concern with other inhibitors of the Janus kinase family of enzymes, Emma Guttman, MD, PhD, said at the annual meeting of the American Academy of Dermatology.

The study’s primary endpoint was the mean percent EASI improvement from baseline. Dr. Guttman reported several of the key secondary endpoints as well.

On the primary endpoint, all three doses of upadacitinib separated from placebo quickly and dramatically. Patients began to see some skin clearance after 1 week; by 2 weeks, the 7.5-mg group had achieved a 39% improvement and the 15- and 30-mg groups, 56% and 59% improvement, respectively.

Efficacy in the 7.5-mg group peaked at a 50% improvement by week 4, and then trailed off somewhat, with a mean 39% improvement by week 16.

Efficacy in the two higher dose groups also peaked around 4 weeks, with a 66% improvement in the 15-mg group and a 78% improvement in the 30-mg group. There was some tailing off of effect in each of these groups as well. By 16 weeks, the mean EASI improvement was 61.7% in the 15-mg group and 74.4% in the 30-mg group.

A good number of patients in each dosing group even achieved 90% skin clearance, Dr. Guttman noted.

“We generally say that we like to see an EASI 50, but now we are talking about EASI 75 and even 90. More than 60% on the highest dose achieved an EASI 75 and 60% an EASI 90. Even the 15-mg group achieved a nice EASI 90 response, at around 26%.”

Itching also responded well to upadacitinib, Dr. Guttman said. Within 1 week, all three active groups had separated significantly from the placebo group. By 2 weeks, the 7.5-mg group had a mean 29% improvement on the pruritus numerical rating scale. The improvement was 46% in the 15-mg group and 57.6% in the 30-mg group. By 16 weeks, the improvements were 39.6%, 48%, and 68.9%, respectively, compared with 9.7% among those on placebo.

The most common treatment-emergent adverse event was upper respiratory infection, which Dr. Guttman noted has been seen with JAK inhibitors. This occurred in 10% of those taking placebo and in 16.7% of the 7.5-mg group and 11.9% of both the 15-mg and 30-mg groups. A few patients experienced exacerbation of their AD on the medication (16.7%, 7% and 11.9% of the active groups, compared with 7.5% of those on placebo). New acne developed in 2.5% of placebo patients and in 9.5%, 4.8%, and 14.3% of those taking upadacitinib. The acne was on the body, considered mild, and resolved, Dr. Guttman said.

Two patients taking 7.5 mg and one taking 15 mg developed a serious infection, although she did not elaborate on the illnesses. Two taking 15 mg developed a liver disorder. There were four cases of neutropenia and one lymphopenia, all among the active groups. Creatine phosphokinase elevations occurred in one taking placebo and seven taking the study drug.

There were no pulmonary or deep vein thromboses; no opportunistic infections or malignancies; and no cases of herpes zoster, tuberculosis, or renal dysfunction. There were no deaths during the trial.

Phase 3 studies of upadacitinib in patients with rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease are underway, according to AbbVie.

AbbVie sponsored the AD study. Dr. Guttman is a consultant for the company.
 

msullivan@frontlinemedcom.com

SOURCE: Guttman E et al. AAD late-breaking clinical trials, Abstract 6533

SAN DIEGO – Patch testing may be in order for some patients with atopic dermatitis, according to Jonathan Silverberg, MD, PhD, of the department of dermatology, Northwestern University, Chicago.

Allergic contact dermatitis is a common comorbid condition in people with AD “and sometimes, can flare up the severity of the disease,” he said in a video interview at the American Academy of Dermatology annual meeting.

Patch testing can ferret out a trigger in atopic dermatitis patients with atypical disease distribution or refractory disease, and help avoid the need for systemic therapy, Dr. Silverman pointed out.

In the interview, he discussed these and other clinical scenarios, as well as how patch testing differs in these patients and what screening series to consider using.

Dr. Silverberg had no relevant financial disclosures.

emechcatie@frontlinemedcom.com

SOURCE: Silverberg, J. et al, Session 061.

SAN DIEGO – Patch testing may be in order for some patients with atopic dermatitis, according to Jonathan Silverberg, MD, PhD, of the department of dermatology, Northwestern University, Chicago.

Allergic contact dermatitis is a common comorbid condition in people with AD “and sometimes, can flare up the severity of the disease,” he said in a video interview at the American Academy of Dermatology annual meeting.

Patch testing can ferret out a trigger in atopic dermatitis patients with atypical disease distribution or refractory disease, and help avoid the need for systemic therapy, Dr. Silverman pointed out.

In the interview, he discussed these and other clinical scenarios, as well as how patch testing differs in these patients and what screening series to consider using.

Dr. Silverberg had no relevant financial disclosures.

emechcatie@frontlinemedcom.com

SOURCE: Silverberg, J. et al, Session 061.

SAN DIEGO – Patch testing may be in order for some patients with atopic dermatitis, according to Jonathan Silverberg, MD, PhD, of the department of dermatology, Northwestern University, Chicago.

Allergic contact dermatitis is a common comorbid condition in people with AD “and sometimes, can flare up the severity of the disease,” he said in a video interview at the American Academy of Dermatology annual meeting.

Patch testing can ferret out a trigger in atopic dermatitis patients with atypical disease distribution or refractory disease, and help avoid the need for systemic therapy, Dr. Silverman pointed out.

In the interview, he discussed these and other clinical scenarios, as well as how patch testing differs in these patients and what screening series to consider using.

Dr. Silverberg had no relevant financial disclosures.

emechcatie@frontlinemedcom.com

SOURCE: Silverberg, J. et al, Session 061.

SAN DIEGO – Over the past few years, pediatric dermatologist Kalyani Marathe, MD, has been seeing young patients with vulvar diseases in a multidisciplinary vulvar dermatology clinic at Children’s National Health System, in Washington, DC.

When Dr. Marathe started, it was her first experience treating such patients and there still are not much data in this population. She and Veronica Gomez-Lobo, MD, a pediatric and adolescent gynecologist at Children’s, “have now been doing the clinic every month for the last three and a half years,” and counsel and treat patients together. With longitudinal follow-up, “we’re learning so much about these conditions in children,” most of whom are about ages 3-11 years.

In a video interview at the annual meeting of the American Academy of Dermatology, Dr. Marathe discussed some of what she and Dr. Gomez-Lobo have learned over the past 3 years, with algorithms for treatment for the most common conditions they encounter in the clinic: non-specific vulvovaginitis, lichen sclerosus, and vitiligo.

Dr. Marathe had no relevant disclosures. She is a Dermatology News editorial board advisor.

emechcatie@frontlinemedcom.com

SOURCE: Marathe, K. et al, Session U018

SAN DIEGO – Over the past few years, pediatric dermatologist Kalyani Marathe, MD, has been seeing young patients with vulvar diseases in a multidisciplinary vulvar dermatology clinic at Children’s National Health System, in Washington, DC.

When Dr. Marathe started, it was her first experience treating such patients and there still are not much data in this population. She and Veronica Gomez-Lobo, MD, a pediatric and adolescent gynecologist at Children’s, “have now been doing the clinic every month for the last three and a half years,” and counsel and treat patients together. With longitudinal follow-up, “we’re learning so much about these conditions in children,” most of whom are about ages 3-11 years.

In a video interview at the annual meeting of the American Academy of Dermatology, Dr. Marathe discussed some of what she and Dr. Gomez-Lobo have learned over the past 3 years, with algorithms for treatment for the most common conditions they encounter in the clinic: non-specific vulvovaginitis, lichen sclerosus, and vitiligo.

Dr. Marathe had no relevant disclosures. She is a Dermatology News editorial board advisor.

emechcatie@frontlinemedcom.com

SOURCE: Marathe, K. et al, Session U018

SAN DIEGO – Over the past few years, pediatric dermatologist Kalyani Marathe, MD, has been seeing young patients with vulvar diseases in a multidisciplinary vulvar dermatology clinic at Children’s National Health System, in Washington, DC.

When Dr. Marathe started, it was her first experience treating such patients and there still are not much data in this population. She and Veronica Gomez-Lobo, MD, a pediatric and adolescent gynecologist at Children’s, “have now been doing the clinic every month for the last three and a half years,” and counsel and treat patients together. With longitudinal follow-up, “we’re learning so much about these conditions in children,” most of whom are about ages 3-11 years.

In a video interview at the annual meeting of the American Academy of Dermatology, Dr. Marathe discussed some of what she and Dr. Gomez-Lobo have learned over the past 3 years, with algorithms for treatment for the most common conditions they encounter in the clinic: non-specific vulvovaginitis, lichen sclerosus, and vitiligo.

Dr. Marathe had no relevant disclosures. She is a Dermatology News editorial board advisor.

emechcatie@frontlinemedcom.com

SOURCE: Marathe, K. et al, Session U018

SAN DIEGO – Risankizumab outperformed ustekinumab in two phase 3 trials investigating the IL-23 blocker for moderate to severe plaque psoriasis.

In two year-long studies, 56% and 59% of those taking risankizumab and 21% and 30% of those taking ustekinumab achieved completely clear skin, Kenneth B. Gordon, MD, said at the annual meeting of the American Academy of Dermatology.

Bruce Jancin/Frontline Medical News

“One of the things we are striving for now is complete skin clearance,” said Dr. Gordon, chair of the dermatology department the Medical College of Wisconsin, Milwaukee. “In the past, people have said that it wasn’t important to reach that, yet here we are, getting more than 50% of patients to that point.”

Risankizumab is an investigational monoclonal antibody that selectively blocks IL-23, a key inflammatory protein. The drug is also in phase 3 trials for Crohn's disease, and being investigated for psoriatic arthritis. AbbVie, which is developing risankizumab, plans future trials for treating ulcerative colitis.

Dr. Gordon reported the results of UltIMMa-1 and UltIMMa-2, identical three-armed studies that randomized a total of 797 patients with moderate to severe plaque psoriasis to risankizumab 150 mg, ustekinumab 45 mg or 90 mg (based on weight), or to a crossover group that took placebo for the first 16 weeks of the study and then were switched to risankizumab 150 mg for the remainder of the study. Study drugs were delivered at weeks 0, 4, 16, 28, and 40.

The coprimary endpoints were at least a 90% improvement in the Psoriasis Area Severity Index score (PASI 90) at week 16 and a score of 0 or 1 on the Static Physicians’ Assessment scale (sPGA 0/1) at week 16, compared with placebo. Key secondary endpoints compared risankizumab with ustekinumab: PASI 90, sPGA score of clear (sPGA 0), sPGA 0/1, and Dermatology Quality of Life (DLQI) score of 0/1 at week 16, and PASI 90, PASI 100 and sPGA 0 at week 52.

In both trials, patients were 48 years old on average; about 20% had severe plaque psoriasis. The mean PASI score was about 20 at trial entry. Prior therapy included biologics in 30%-43%, depending on the trial, and TNF-alpha inhibitors in about 25%.

Patient retention in the study was good, Dr. Gordon noted, with 95% of risankizumab patients still taking the drug at 52 weeks. Patients also stayed on ustekinumab, with 94% of UltIMMa-1 patients and 91% of UltIMMa-2 patients still taking the drug at 52 weeks.

At week 16, risankizumab was clearly superior to placebo in both endpoints. In both studies, 75% of actively treated patients achieved PASI 90, compared to 5% of those taking placebo. In UltIMMa-1, a clear or almost clear sPGA was seen in 88% of risankizumab patients as compared to 8% of those taking placebo. In UltIMMa-2, these numbers were 84% and 5%, respectively.

In the secondary comparison of the two active drugs, risankizumab significantly outperformed ustekinumab on PASI90 at 16 weeks in UltIMMa-1 (75% vs. 42%) and in UltIMMa-2 (75% vs. 47%). The PASI90 outcomes similarly favored risankizumab at 52 weeks in UltIMMa-1 (82% vs. 44%) and in UltIMMa-2 (81% vs. 50%).

As compared with ustekinumab, risankizumab aced the secondary endpoint of complete skin clearance in UltIMMa-1 and (36% vs. 12%) and UltIMMa-2 (51% vs. 24%). The results similarly favored risankizumab at 52 weeks in both trials (56% vs. 21% and 59% vs. 30%).

Another secondary endpoint looked at how the crossover group fared. At week 51, the PASI90 for this group was 78% in UltIMMa-1 and 85% in UltIMMa-2; the PASI100 at 52 weeks for these patients was 55% and 67%.

A responder time curve demonstrated just how quickly the crossover patients made up for lost time after switching to risankizumab. Although these patients made no progress toward disease clearance during their placebo period, they quickly caught up with the primary risankizumab group. At 16 weeks, 5% in this group had a PASI 90; by week 28, 51% did; and by week 52, PASI 90 topped out at 78%.

“The time course seen in this trial is very important,” Dr. Gordon said. “By 8 weeks, almost 44% [of the primary risankizumab group] was already at PASI90. They reached an extremely high level of response that was very consistent over 1 year. In the ustekinumab group, we saw some saw-toothing of response, indicating that people were losing effectiveness at the end of the dosing period. With risankizumab, we did not see that, indicating that the once every 12 weeks dosing period is effective.”

The DLQI 0/1 outcome occurred at 16 and 52 weeks in significantly more patients taking risankizumab in both studies. By week 52 in UltIMMa-1, 75% of patients on risankizumab had achieved a DLQ1 0/1, compared with 47% of the ustekinumab group. In UltIMMa-2, these numbers were 71% and 44%, with the crossover group posting scores similar to the primary risankizumab group in both studies (62% and 68%).

Risankizumab proved safe and well tolerated, Dr. Gordon said. Less than 1% of patients discontinued the medication due to an adverse event. In both the UltIMMa-1 and UltIMMa-2 trials, the most frequently reported treatment-emergent adverse event in the risankizumab groups was upper respiratory tract infection. In UltIMMa-1, one patient receiving risankizumab presented with latent tuberculosis and was treated with rifampicin. There were no new cases of tuberculosis.

The serious adverse event rate hovered between 2%-3% in both trials. The rate of serious infection was 1%. The rate of malignancy was 0.3%, but fell to 0 when nonmelanoma skin cancer was excluded. There were no major cardiovascular events.

"Not only do these data show significant rates of clear skin, but because we know the burden of psoriasis extends beyond the skin, we are encouraged by the patient-reported improvement in quality of life after one year of treatment," he said. "Given the significant impact of psoriasis, it is important to continue to investigate additional treatment options."

AbbVie sponsored the trials. Dr. Gordon is a consultant for the company.

msullivan@frontlinemedcom.com

SOURCE: Gordon et al. AAD, Abstract 6495

SAN DIEGO – Risankizumab outperformed ustekinumab in two phase 3 trials investigating the IL-23 blocker for moderate to severe plaque psoriasis.

In two year-long studies, 56% and 59% of those taking risankizumab and 21% and 30% of those taking ustekinumab achieved completely clear skin, Kenneth B. Gordon, MD, said at the annual meeting of the American Academy of Dermatology.

Bruce Jancin/Frontline Medical News

“One of the things we are striving for now is complete skin clearance,” said Dr. Gordon, chair of the dermatology department the Medical College of Wisconsin, Milwaukee. “In the past, people have said that it wasn’t important to reach that, yet here we are, getting more than 50% of patients to that point.”

Risankizumab is an investigational monoclonal antibody that selectively blocks IL-23, a key inflammatory protein. The drug is also in phase 3 trials for Crohn's disease, and being investigated for psoriatic arthritis. AbbVie, which is developing risankizumab, plans future trials for treating ulcerative colitis.

Dr. Gordon reported the results of UltIMMa-1 and UltIMMa-2, identical three-armed studies that randomized a total of 797 patients with moderate to severe plaque psoriasis to risankizumab 150 mg, ustekinumab 45 mg or 90 mg (based on weight), or to a crossover group that took placebo for the first 16 weeks of the study and then were switched to risankizumab 150 mg for the remainder of the study. Study drugs were delivered at weeks 0, 4, 16, 28, and 40.

The coprimary endpoints were at least a 90% improvement in the Psoriasis Area Severity Index score (PASI 90) at week 16 and a score of 0 or 1 on the Static Physicians’ Assessment scale (sPGA 0/1) at week 16, compared with placebo. Key secondary endpoints compared risankizumab with ustekinumab: PASI 90, sPGA score of clear (sPGA 0), sPGA 0/1, and Dermatology Quality of Life (DLQI) score of 0/1 at week 16, and PASI 90, PASI 100 and sPGA 0 at week 52.

In both trials, patients were 48 years old on average; about 20% had severe plaque psoriasis. The mean PASI score was about 20 at trial entry. Prior therapy included biologics in 30%-43%, depending on the trial, and TNF-alpha inhibitors in about 25%.

Patient retention in the study was good, Dr. Gordon noted, with 95% of risankizumab patients still taking the drug at 52 weeks. Patients also stayed on ustekinumab, with 94% of UltIMMa-1 patients and 91% of UltIMMa-2 patients still taking the drug at 52 weeks.

At week 16, risankizumab was clearly superior to placebo in both endpoints. In both studies, 75% of actively treated patients achieved PASI 90, compared to 5% of those taking placebo. In UltIMMa-1, a clear or almost clear sPGA was seen in 88% of risankizumab patients as compared to 8% of those taking placebo. In UltIMMa-2, these numbers were 84% and 5%, respectively.

In the secondary comparison of the two active drugs, risankizumab significantly outperformed ustekinumab on PASI90 at 16 weeks in UltIMMa-1 (75% vs. 42%) and in UltIMMa-2 (75% vs. 47%). The PASI90 outcomes similarly favored risankizumab at 52 weeks in UltIMMa-1 (82% vs. 44%) and in UltIMMa-2 (81% vs. 50%).

As compared with ustekinumab, risankizumab aced the secondary endpoint of complete skin clearance in UltIMMa-1 and (36% vs. 12%) and UltIMMa-2 (51% vs. 24%). The results similarly favored risankizumab at 52 weeks in both trials (56% vs. 21% and 59% vs. 30%).

Another secondary endpoint looked at how the crossover group fared. At week 51, the PASI90 for this group was 78% in UltIMMa-1 and 85% in UltIMMa-2; the PASI100 at 52 weeks for these patients was 55% and 67%.

A responder time curve demonstrated just how quickly the crossover patients made up for lost time after switching to risankizumab. Although these patients made no progress toward disease clearance during their placebo period, they quickly caught up with the primary risankizumab group. At 16 weeks, 5% in this group had a PASI 90; by week 28, 51% did; and by week 52, PASI 90 topped out at 78%.

“The time course seen in this trial is very important,” Dr. Gordon said. “By 8 weeks, almost 44% [of the primary risankizumab group] was already at PASI90. They reached an extremely high level of response that was very consistent over 1 year. In the ustekinumab group, we saw some saw-toothing of response, indicating that people were losing effectiveness at the end of the dosing period. With risankizumab, we did not see that, indicating that the once every 12 weeks dosing period is effective.”

The DLQI 0/1 outcome occurred at 16 and 52 weeks in significantly more patients taking risankizumab in both studies. By week 52 in UltIMMa-1, 75% of patients on risankizumab had achieved a DLQ1 0/1, compared with 47% of the ustekinumab group. In UltIMMa-2, these numbers were 71% and 44%, with the crossover group posting scores similar to the primary risankizumab group in both studies (62% and 68%).

Risankizumab proved safe and well tolerated, Dr. Gordon said. Less than 1% of patients discontinued the medication due to an adverse event. In both the UltIMMa-1 and UltIMMa-2 trials, the most frequently reported treatment-emergent adverse event in the risankizumab groups was upper respiratory tract infection. In UltIMMa-1, one patient receiving risankizumab presented with latent tuberculosis and was treated with rifampicin. There were no new cases of tuberculosis.

The serious adverse event rate hovered between 2%-3% in both trials. The rate of serious infection was 1%. The rate of malignancy was 0.3%, but fell to 0 when nonmelanoma skin cancer was excluded. There were no major cardiovascular events.

"Not only do these data show significant rates of clear skin, but because we know the burden of psoriasis extends beyond the skin, we are encouraged by the patient-reported improvement in quality of life after one year of treatment," he said. "Given the significant impact of psoriasis, it is important to continue to investigate additional treatment options."

AbbVie sponsored the trials. Dr. Gordon is a consultant for the company.

msullivan@frontlinemedcom.com

SOURCE: Gordon et al. AAD, Abstract 6495

SAN DIEGO – Risankizumab outperformed ustekinumab in two phase 3 trials investigating the IL-23 blocker for moderate to severe plaque psoriasis.

In two year-long studies, 56% and 59% of those taking risankizumab and 21% and 30% of those taking ustekinumab achieved completely clear skin, Kenneth B. Gordon, MD, said at the annual meeting of the American Academy of Dermatology.

Bruce Jancin/Frontline Medical News

“One of the things we are striving for now is complete skin clearance,” said Dr. Gordon, chair of the dermatology department the Medical College of Wisconsin, Milwaukee. “In the past, people have said that it wasn’t important to reach that, yet here we are, getting more than 50% of patients to that point.”

Risankizumab is an investigational monoclonal antibody that selectively blocks IL-23, a key inflammatory protein. The drug is also in phase 3 trials for Crohn's disease, and being investigated for psoriatic arthritis. AbbVie, which is developing risankizumab, plans future trials for treating ulcerative colitis.

Dr. Gordon reported the results of UltIMMa-1 and UltIMMa-2, identical three-armed studies that randomized a total of 797 patients with moderate to severe plaque psoriasis to risankizumab 150 mg, ustekinumab 45 mg or 90 mg (based on weight), or to a crossover group that took placebo for the first 16 weeks of the study and then were switched to risankizumab 150 mg for the remainder of the study. Study drugs were delivered at weeks 0, 4, 16, 28, and 40.

The coprimary endpoints were at least a 90% improvement in the Psoriasis Area Severity Index score (PASI 90) at week 16 and a score of 0 or 1 on the Static Physicians’ Assessment scale (sPGA 0/1) at week 16, compared with placebo. Key secondary endpoints compared risankizumab with ustekinumab: PASI 90, sPGA score of clear (sPGA 0), sPGA 0/1, and Dermatology Quality of Life (DLQI) score of 0/1 at week 16, and PASI 90, PASI 100 and sPGA 0 at week 52.

In both trials, patients were 48 years old on average; about 20% had severe plaque psoriasis. The mean PASI score was about 20 at trial entry. Prior therapy included biologics in 30%-43%, depending on the trial, and TNF-alpha inhibitors in about 25%.

Patient retention in the study was good, Dr. Gordon noted, with 95% of risankizumab patients still taking the drug at 52 weeks. Patients also stayed on ustekinumab, with 94% of UltIMMa-1 patients and 91% of UltIMMa-2 patients still taking the drug at 52 weeks.

At week 16, risankizumab was clearly superior to placebo in both endpoints. In both studies, 75% of actively treated patients achieved PASI 90, compared to 5% of those taking placebo. In UltIMMa-1, a clear or almost clear sPGA was seen in 88% of risankizumab patients as compared to 8% of those taking placebo. In UltIMMa-2, these numbers were 84% and 5%, respectively.

In the secondary comparison of the two active drugs, risankizumab significantly outperformed ustekinumab on PASI90 at 16 weeks in UltIMMa-1 (75% vs. 42%) and in UltIMMa-2 (75% vs. 47%). The PASI90 outcomes similarly favored risankizumab at 52 weeks in UltIMMa-1 (82% vs. 44%) and in UltIMMa-2 (81% vs. 50%).

As compared with ustekinumab, risankizumab aced the secondary endpoint of complete skin clearance in UltIMMa-1 and (36% vs. 12%) and UltIMMa-2 (51% vs. 24%). The results similarly favored risankizumab at 52 weeks in both trials (56% vs. 21% and 59% vs. 30%).

Another secondary endpoint looked at how the crossover group fared. At week 51, the PASI90 for this group was 78% in UltIMMa-1 and 85% in UltIMMa-2; the PASI100 at 52 weeks for these patients was 55% and 67%.

A responder time curve demonstrated just how quickly the crossover patients made up for lost time after switching to risankizumab. Although these patients made no progress toward disease clearance during their placebo period, they quickly caught up with the primary risankizumab group. At 16 weeks, 5% in this group had a PASI 90; by week 28, 51% did; and by week 52, PASI 90 topped out at 78%.

“The time course seen in this trial is very important,” Dr. Gordon said. “By 8 weeks, almost 44% [of the primary risankizumab group] was already at PASI90. They reached an extremely high level of response that was very consistent over 1 year. In the ustekinumab group, we saw some saw-toothing of response, indicating that people were losing effectiveness at the end of the dosing period. With risankizumab, we did not see that, indicating that the once every 12 weeks dosing period is effective.”

The DLQI 0/1 outcome occurred at 16 and 52 weeks in significantly more patients taking risankizumab in both studies. By week 52 in UltIMMa-1, 75% of patients on risankizumab had achieved a DLQ1 0/1, compared with 47% of the ustekinumab group. In UltIMMa-2, these numbers were 71% and 44%, with the crossover group posting scores similar to the primary risankizumab group in both studies (62% and 68%).

Risankizumab proved safe and well tolerated, Dr. Gordon said. Less than 1% of patients discontinued the medication due to an adverse event. In both the UltIMMa-1 and UltIMMa-2 trials, the most frequently reported treatment-emergent adverse event in the risankizumab groups was upper respiratory tract infection. In UltIMMa-1, one patient receiving risankizumab presented with latent tuberculosis and was treated with rifampicin. There were no new cases of tuberculosis.

The serious adverse event rate hovered between 2%-3% in both trials. The rate of serious infection was 1%. The rate of malignancy was 0.3%, but fell to 0 when nonmelanoma skin cancer was excluded. There were no major cardiovascular events.

"Not only do these data show significant rates of clear skin, but because we know the burden of psoriasis extends beyond the skin, we are encouraged by the patient-reported improvement in quality of life after one year of treatment," he said. "Given the significant impact of psoriasis, it is important to continue to investigate additional treatment options."

AbbVie sponsored the trials. Dr. Gordon is a consultant for the company.

msullivan@frontlinemedcom.com

SOURCE: Gordon et al. AAD, Abstract 6495

Patients with painful skin conditions need pain management that is provided by their dermatologists, Robert G. Micheletti, MD, contended in a presentation at the annual meeting of the American Academy of Dermatology.

Dermatologists are the experts when it comes to treating painful skin conditions like pyoderma gangrenosum, hidradenitis suppurativa, calciphylaxis, and vasculopathies. “We should be willing to treat the pain that goes with (these conditions), at least within our scope of practice,” said Dr. Micheletti, co-director of the Inpatient Dermatology Consult Service at the University of Pennsylvania, Philadelphia. “At the same time, we know opioids should be prescribed only when necessary, at the lowest effective dose, and for the shortest possible duration.”

In our exclusive video interview, Dr. Micheletti outlined the keys to successful care of patients with painful skin disease. He described patient characteristics that influence prescribing choices and tips for accurately assessing pain needs with a preference for a conservative regimen that utilizes non-opioids and avoids over-reliance on narcotics.

Source: Micheletti, R., Session F013

Patients with painful skin conditions need pain management that is provided by their dermatologists, Robert G. Micheletti, MD, contended in a presentation at the annual meeting of the American Academy of Dermatology.

Dermatologists are the experts when it comes to treating painful skin conditions like pyoderma gangrenosum, hidradenitis suppurativa, calciphylaxis, and vasculopathies. “We should be willing to treat the pain that goes with (these conditions), at least within our scope of practice,” said Dr. Micheletti, co-director of the Inpatient Dermatology Consult Service at the University of Pennsylvania, Philadelphia. “At the same time, we know opioids should be prescribed only when necessary, at the lowest effective dose, and for the shortest possible duration.”

In our exclusive video interview, Dr. Micheletti outlined the keys to successful care of patients with painful skin disease. He described patient characteristics that influence prescribing choices and tips for accurately assessing pain needs with a preference for a conservative regimen that utilizes non-opioids and avoids over-reliance on narcotics.

Source: Micheletti, R., Session F013

Patients with painful skin conditions need pain management that is provided by their dermatologists, Robert G. Micheletti, MD, contended in a presentation at the annual meeting of the American Academy of Dermatology.

Dermatologists are the experts when it comes to treating painful skin conditions like pyoderma gangrenosum, hidradenitis suppurativa, calciphylaxis, and vasculopathies. “We should be willing to treat the pain that goes with (these conditions), at least within our scope of practice,” said Dr. Micheletti, co-director of the Inpatient Dermatology Consult Service at the University of Pennsylvania, Philadelphia. “At the same time, we know opioids should be prescribed only when necessary, at the lowest effective dose, and for the shortest possible duration.”

In our exclusive video interview, Dr. Micheletti outlined the keys to successful care of patients with painful skin disease. He described patient characteristics that influence prescribing choices and tips for accurately assessing pain needs with a preference for a conservative regimen that utilizes non-opioids and avoids over-reliance on narcotics.

Source: Micheletti, R., Session F013

SAN DIEGO – The path to successful treatment of patients with imagined skin disorders is paved with compassion, according to John Koo, MD, a dermatologist and psychiatrist with the University of California at San Francisco.

When a patient presents with delusional parasitosis -- horror stories about imagined infestations of parasites or bugs – the key to successful treatment is a positive attitude and validation, not denial, Dr. Koo said in a presentation at the annual meeting of the American Academy of Dermatology.

"I cannot afford to go in (the exam room) with a long face," he said. "If I go in and I’m not looking happy, things can deteriorate quickly. So I make sure I go in with the biggest smile on my face like I'm meeting my favorite Hollywood star."

"When I say something like 'It's like a living hell, isn't it,' patients are really touched, he said. The patient’s response is typically 'You're the first dermatologist to understand what I'm going through.' You cannot endorse their delusion, but you can endorse their suffering."

In our video interview, Dr. Koo delved into techniques for the successful work-up and evaluation of patients with delusional parasitosis, the varying degrees of the condition, medications used for treatment, and the prospects for eventual drug-free relief.

Dr. Koo reports no relevant financial disclosures.

SAN DIEGO – The path to successful treatment of patients with imagined skin disorders is paved with compassion, according to John Koo, MD, a dermatologist and psychiatrist with the University of California at San Francisco.

When a patient presents with delusional parasitosis -- horror stories about imagined infestations of parasites or bugs – the key to successful treatment is a positive attitude and validation, not denial, Dr. Koo said in a presentation at the annual meeting of the American Academy of Dermatology.

"I cannot afford to go in (the exam room) with a long face," he said. "If I go in and I’m not looking happy, things can deteriorate quickly. So I make sure I go in with the biggest smile on my face like I'm meeting my favorite Hollywood star."

"When I say something like 'It's like a living hell, isn't it,' patients are really touched, he said. The patient’s response is typically 'You're the first dermatologist to understand what I'm going through.' You cannot endorse their delusion, but you can endorse their suffering."

In our video interview, Dr. Koo delved into techniques for the successful work-up and evaluation of patients with delusional parasitosis, the varying degrees of the condition, medications used for treatment, and the prospects for eventual drug-free relief.

Dr. Koo reports no relevant financial disclosures.

SAN DIEGO – The path to successful treatment of patients with imagined skin disorders is paved with compassion, according to John Koo, MD, a dermatologist and psychiatrist with the University of California at San Francisco.

When a patient presents with delusional parasitosis -- horror stories about imagined infestations of parasites or bugs – the key to successful treatment is a positive attitude and validation, not denial, Dr. Koo said in a presentation at the annual meeting of the American Academy of Dermatology.

"I cannot afford to go in (the exam room) with a long face," he said. "If I go in and I’m not looking happy, things can deteriorate quickly. So I make sure I go in with the biggest smile on my face like I'm meeting my favorite Hollywood star."

"When I say something like 'It's like a living hell, isn't it,' patients are really touched, he said. The patient’s response is typically 'You're the first dermatologist to understand what I'm going through.' You cannot endorse their delusion, but you can endorse their suffering."

In our video interview, Dr. Koo delved into techniques for the successful work-up and evaluation of patients with delusional parasitosis, the varying degrees of the condition, medications used for treatment, and the prospects for eventual drug-free relief.

Dr. Koo reports no relevant financial disclosures.

SAN DIEGO – A topical anticholinergic drug, glycopyrronium tosylate, was as safe and effective for treating hyperhidrosis in children 9-16 years old as it was in adults in two phase 3 trials that included 25 treated children, raising the prospect it could become the first drug to gain Food and Drug Administration approval for treating pediatric hyperhidrosis.

“Topical glycopyrronium tosylate treatment may provide a much needed treatment option for those with primary axillary hyperhidrosis, including pediatric patients,” Adelaide A. Hebert, MD, said at the annual meeting of the American Academy of Dermatology.

Mitchel L. Zoler/Frontline Medical News

The data she reported from a post hoc analysis included 25 children. 9-16 years old, who received a daily, topical application of glycopyrronium tosylate to their underarms for 4 weeks and 19 children treated with vehicle only. The children were enrolled in either of a pair of phase 3 pivotal trials that together randomized 697 patients. In November 2017, Dermira, the company developing this drug, submitted an application to the FDA for marketing approval of the agent for adults and children at least 9 years old. A statement from the company said an FDA decision is expected by mid-2018. 

Getting approval from the FDA for an effective pediatric hyperhidrosis treatment would be an important advance because nothing now exists in that space, said Dr. Hebert, professor of dermatology and pediatrics and director of pediatric dermatology at the University of Texas Health Sciences Center at Houston.

Based on past FDA actions, safety data from 25 children should be adequate to support pediatric labeling, she said in an interview, though she added that confirmatory safety data from a phase 4 study in children would be a welcome future addition. Hyperhydrosis in adolescents is “underappreciated, underdiagnosed, and is very impactful,” and currently has limited treatment options that are readily available for children, especially effective options for more severe hyperhidrosis.

The pediatric data came from the phase 3, randomized, double-blind, vehicle-controlled ATMOS-1 (DRM04 in Subjects With Axillary Hyperhidrosis) trial. The trial ran at several U.S. and German centers, although only the U.S. centers enrolled pediatric patients.

The two trials enrolled patients with “intolerable or barely tolerable” primary, axillary hyperhidrosis of at least 6 months' duration. After 4 weeks, patients treated with glycopyrronium tosylate had improvements in their daily diary account of axillary sweating and in sweat production. Dr. Hebert and her associates reported overall results from the two trials at various prior dermatology meetings, and the company reported some of the results in a press release, but the results have not yet been published in a journal.

The new, pediatric analysis that Dr. Hebert reported showed that the responder rate based on a 4 point or greater improvement in daily sweat diary assessments occurred in 60% of the actively treated children and in 13% of the controls. A 50% or greater reduction in sweat production occurred in 80% of the treated children and in 55% of controls. Quality of life, measured using the Children’s Dermatology Life Quality Index improved by an average of 8 points among the treated children, compared with an average 2-point improvement among the controls. This level of improvement among the glycopyrronium-treated patients would have been enough to move patients from the moderate-effect category at baseline to a no- or small-effect category.

The treatment was generally well tolerated, with no serious adverse effects reported and with treatment effects that were primarily as expected from an anticholinergic agent, including dry mouth, pupil dilation, and blurred vision. One of the 25 treated children withdrew because of these effects, which then resolved. Blood testing showed no systemic absorption of the drug, Dr. Hebert said.

The ATMOS-1 and ATMOS-2 trials were sponsored by Dermira, the company developing glycopyrronium tosylate. Dr. Hebert has been a consultant to and has received research funding from Dermira, and some of the coauthors of the study are Dermira employees. Dr. Hebert is an advisor to the editorial board of Dermatology News.

mzoler@frontlinemedcom.com

SOURCE: Hebert A et al. Annual meeting of the American Academy of Dermatology Abstract 6659.

SAN DIEGO – A topical anticholinergic drug, glycopyrronium tosylate, was as safe and effective for treating hyperhidrosis in children 9-16 years old as it was in adults in two phase 3 trials that included 25 treated children, raising the prospect it could become the first drug to gain Food and Drug Administration approval for treating pediatric hyperhidrosis.

“Topical glycopyrronium tosylate treatment may provide a much needed treatment option for those with primary axillary hyperhidrosis, including pediatric patients,” Adelaide A. Hebert, MD, said at the annual meeting of the American Academy of Dermatology.

Mitchel L. Zoler/Frontline Medical News

The data she reported from a post hoc analysis included 25 children. 9-16 years old, who received a daily, topical application of glycopyrronium tosylate to their underarms for 4 weeks and 19 children treated with vehicle only. The children were enrolled in either of a pair of phase 3 pivotal trials that together randomized 697 patients. In November 2017, Dermira, the company developing this drug, submitted an application to the FDA for marketing approval of the agent for adults and children at least 9 years old. A statement from the company said an FDA decision is expected by mid-2018. 

Getting approval from the FDA for an effective pediatric hyperhidrosis treatment would be an important advance because nothing now exists in that space, said Dr. Hebert, professor of dermatology and pediatrics and director of pediatric dermatology at the University of Texas Health Sciences Center at Houston.

Based on past FDA actions, safety data from 25 children should be adequate to support pediatric labeling, she said in an interview, though she added that confirmatory safety data from a phase 4 study in children would be a welcome future addition. Hyperhydrosis in adolescents is “underappreciated, underdiagnosed, and is very impactful,” and currently has limited treatment options that are readily available for children, especially effective options for more severe hyperhidrosis.

The pediatric data came from the phase 3, randomized, double-blind, vehicle-controlled ATMOS-1 (DRM04 in Subjects With Axillary Hyperhidrosis) trial. The trial ran at several U.S. and German centers, although only the U.S. centers enrolled pediatric patients.

The two trials enrolled patients with “intolerable or barely tolerable” primary, axillary hyperhidrosis of at least 6 months' duration. After 4 weeks, patients treated with glycopyrronium tosylate had improvements in their daily diary account of axillary sweating and in sweat production. Dr. Hebert and her associates reported overall results from the two trials at various prior dermatology meetings, and the company reported some of the results in a press release, but the results have not yet been published in a journal.

The new, pediatric analysis that Dr. Hebert reported showed that the responder rate based on a 4 point or greater improvement in daily sweat diary assessments occurred in 60% of the actively treated children and in 13% of the controls. A 50% or greater reduction in sweat production occurred in 80% of the treated children and in 55% of controls. Quality of life, measured using the Children’s Dermatology Life Quality Index improved by an average of 8 points among the treated children, compared with an average 2-point improvement among the controls. This level of improvement among the glycopyrronium-treated patients would have been enough to move patients from the moderate-effect category at baseline to a no- or small-effect category.

The treatment was generally well tolerated, with no serious adverse effects reported and with treatment effects that were primarily as expected from an anticholinergic agent, including dry mouth, pupil dilation, and blurred vision. One of the 25 treated children withdrew because of these effects, which then resolved. Blood testing showed no systemic absorption of the drug, Dr. Hebert said.

The ATMOS-1 and ATMOS-2 trials were sponsored by Dermira, the company developing glycopyrronium tosylate. Dr. Hebert has been a consultant to and has received research funding from Dermira, and some of the coauthors of the study are Dermira employees. Dr. Hebert is an advisor to the editorial board of Dermatology News.

mzoler@frontlinemedcom.com

SOURCE: Hebert A et al. Annual meeting of the American Academy of Dermatology Abstract 6659.

SAN DIEGO – A topical anticholinergic drug, glycopyrronium tosylate, was as safe and effective for treating hyperhidrosis in children 9-16 years old as it was in adults in two phase 3 trials that included 25 treated children, raising the prospect it could become the first drug to gain Food and Drug Administration approval for treating pediatric hyperhidrosis.

“Topical glycopyrronium tosylate treatment may provide a much needed treatment option for those with primary axillary hyperhidrosis, including pediatric patients,” Adelaide A. Hebert, MD, said at the annual meeting of the American Academy of Dermatology.

Mitchel L. Zoler/Frontline Medical News

The data she reported from a post hoc analysis included 25 children. 9-16 years old, who received a daily, topical application of glycopyrronium tosylate to their underarms for 4 weeks and 19 children treated with vehicle only. The children were enrolled in either of a pair of phase 3 pivotal trials that together randomized 697 patients. In November 2017, Dermira, the company developing this drug, submitted an application to the FDA for marketing approval of the agent for adults and children at least 9 years old. A statement from the company said an FDA decision is expected by mid-2018. 

Getting approval from the FDA for an effective pediatric hyperhidrosis treatment would be an important advance because nothing now exists in that space, said Dr. Hebert, professor of dermatology and pediatrics and director of pediatric dermatology at the University of Texas Health Sciences Center at Houston.

Based on past FDA actions, safety data from 25 children should be adequate to support pediatric labeling, she said in an interview, though she added that confirmatory safety data from a phase 4 study in children would be a welcome future addition. Hyperhydrosis in adolescents is “underappreciated, underdiagnosed, and is very impactful,” and currently has limited treatment options that are readily available for children, especially effective options for more severe hyperhidrosis.

The pediatric data came from the phase 3, randomized, double-blind, vehicle-controlled ATMOS-1 (DRM04 in Subjects With Axillary Hyperhidrosis) trial. The trial ran at several U.S. and German centers, although only the U.S. centers enrolled pediatric patients.

The two trials enrolled patients with “intolerable or barely tolerable” primary, axillary hyperhidrosis of at least 6 months' duration. After 4 weeks, patients treated with glycopyrronium tosylate had improvements in their daily diary account of axillary sweating and in sweat production. Dr. Hebert and her associates reported overall results from the two trials at various prior dermatology meetings, and the company reported some of the results in a press release, but the results have not yet been published in a journal.

The new, pediatric analysis that Dr. Hebert reported showed that the responder rate based on a 4 point or greater improvement in daily sweat diary assessments occurred in 60% of the actively treated children and in 13% of the controls. A 50% or greater reduction in sweat production occurred in 80% of the treated children and in 55% of controls. Quality of life, measured using the Children’s Dermatology Life Quality Index improved by an average of 8 points among the treated children, compared with an average 2-point improvement among the controls. This level of improvement among the glycopyrronium-treated patients would have been enough to move patients from the moderate-effect category at baseline to a no- or small-effect category.

The treatment was generally well tolerated, with no serious adverse effects reported and with treatment effects that were primarily as expected from an anticholinergic agent, including dry mouth, pupil dilation, and blurred vision. One of the 25 treated children withdrew because of these effects, which then resolved. Blood testing showed no systemic absorption of the drug, Dr. Hebert said.

The ATMOS-1 and ATMOS-2 trials were sponsored by Dermira, the company developing glycopyrronium tosylate. Dr. Hebert has been a consultant to and has received research funding from Dermira, and some of the coauthors of the study are Dermira employees. Dr. Hebert is an advisor to the editorial board of Dermatology News.

mzoler@frontlinemedcom.com

SOURCE: Hebert A et al. Annual meeting of the American Academy of Dermatology Abstract 6659.